Sr. Statistical Programmer I/II
Sr. Statistical Programmer I/II
Develop and validate SAS® programs to produce high quality deliverables within set timelines in accordance with company and regulatory requirements. BS or equivalent relevant education and 5+ years or MS/PhD and 3+ years of software development and/or programming experience in the Biotech, Pharmaceutical, Medical Device, and Health Care industries; years of experience may substitute for education
Designs, develops, evaluates and modifies SAS programs to analyze and evaluate clinical data. Recognizes inconsistencies and initiates resolution of data problems. Implements statistical analysis plans designed to meet project and protocol deadlines; provides expertise in the design and development of clinical trials, protocols and case report forms. Acts as a liaison between clinical management, subcommittees and project teams as needed. Write, test, and assist with the standardization of programs and utilities up to the departmental level. Write requirements and specifications with consideration of cross-protocol consistency, participate in the creation of study level documentation, and assist with the setup of new studies. Ensure adherence to regulatory and company standards at the protocol level.
- Develop and validate SAS® programs to produce high quality deliverables within set timelines in accordance with company and regulatory requirements. The deliverables include datasets, tables, listings and figures
- Review and provide feedback on deliverables from other clinical groups including but not limited to: statistical analysis plans; table, listing, and figure shells; data management plans; data transfer plans; Safety Report Specification; electronic data entry screens; and case report forms
- Clear and proactive communication with Study/Project teams to clarify requirements and specifications, update others on assignment status, and to convey data irregularities
- Provide active support on planned initiatives that facilitate infrastructure and process enhancements within Biometrics
- Provide support for ongoing regulatory and safety reporting
- Train and mentor junior programmers
- BS or equivalent relevant education and 5+ years or MS/PhD and 3+ years of software development and/or programming experience in the Biotech, Pharmaceutical, Medical Device, and Health Care industries; years of experience may substitute for education
- Advanced SAS® skills
- 3+ years of experience in performing statistical programming using SAS® for creating & testing Analysis Datasets, Tables, Listings and Figures for Phase I-IV clinical studies
- 2+ years of experience in writing SAS® Macros.
- Experience with oncology clinical studies
- Experience implementing CDISC standards
- Experience with regulatory submissions (e.g. BLA, NDA, NDS, MAA, etc.)
- Experience with additional programming languages and tools such as S-Plus, R, SPSS, Perl, VBA, MS Access, MS Excel, and SQL that interface with SAS
- Positive attitude and an ability to creatively use programming skills across variety of tasks in the Clinical Programming area]
- Good written and verbal communication skills
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Contact Name Gokul Vasist
Contact Email firstname.lastname@example.org
Contact Phone 425-527-2842